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Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00050596
First received: December 16, 2002
Last updated: June 23, 2011
Last verified: June 2011

December 16, 2002
June 23, 2011
November 2002
November 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00050596 on ClinicalTrials.gov Archive Site
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Comparison Study of MDX-010 (CTLA-4) Alone and Combined With Docetaxel in the Treatment of Patients With Hormone Refractory Prostate Cancer
A Randomized Study Comparing 4 Monthly Doses of MDX-010 (CTLA-4) as a Single Agent or Used in Combination With a Single Dose of Docetaxel in Patients With Hormone-Refractory Prostate Cancer

The primary objectives of the study are to determine the safety and activity of multiple doses of MDX-010 in patients with hormone-refractory prostate cancer (HRPC), and to determine the safety and activity profile of a single dose of cytotoxic chemotherapy (docetaxel) in combination with MDX-010

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: MDX-010 / MDX-010 + Docetaxel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2004
November 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of adenocarcinoma of the prostate.
  • Metastatic prostate cancer (positive bone scan or measurable disease).
  • Progressive disease after androgen deprivation.
  • No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).

Exclusion Criteria:

  • Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for greater than or equal to 5 years.
  • Previous occurrence of autoimmune disease.
  • Active infection requiring therapy including HIV or chronic hepatitis.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00050596
MDX010-07, CA184-019
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Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP